Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015880
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-08-26
Brief Title:
Testing the Combination of Anti-cancer Drugs Mosunetuzumab Polatuzumab Vedotin and Lenalidomide for the Treatment of RelapsedRefractory Diffuse Large B-Cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Study of Mosunetuzumab With Polatuzumab Vedotin and Lenalidomide MPolaLen in RelapsedRefractory RR Diffuse Large B-Cell Lymphoma DLBCL
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma DLBCL that has come back after a period of improvement relapsed or that has not responded to previous treatment refractory Mosunetuzumab and polatuzumab vedotin are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread Polatuzumab linked to a toxic agent called vedotin attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow Giving mosunetuzumab with polatuzumab vedotin and lenalidomide may work better in treating patients with relapsedrefractory DLBCL
Detailed Description:
PRIMARY OBJECTIVE
I To determine the safety and tolerability of mosunetuzumab polatuzumab vedotin lenalidomide in relapsedrefractory RR diffuse large B cell lymphoma DLBCL
SECONDARY OBJECTIVE
I To observe and record anti-tumor activity of the combination of mosunetuzumab polatuzumab vedotin and lenalidomide in RR DLBCL
EXPLORATORY OBJECTIVES
I To assess the efficacy in patients that have failed prior polatuzumab vedotin containing regimens ie patients who progressedrelapsed after prior polatuzumab
II To assess anti-tumor activity in patients that a have complete response CR or Deauville score of 3 or worse at day 90 D90 or before after standard of care chimeric antigen receptor CAR T-cell therapy b other patients who have failed prior treatment eg relapse after day 90 from CAR-T or relapsed after other therapies and were not considered candidates for CAR-T
III To identify biomarkers that can predict the response to mosunetuzumab polatuzumab vedotin lenalidomide
IV To describe anti-tumor activity in patients whose tumors have previously failed to respond to polatuzumab ie patients who progressedrelapsed after prior polatuzumab
OUTLINE This is a dose-escalation study of mosunetuzumab followed by a dose-expansion study
Patients receive mosunetuzumab intravenously IV over 2-4 hours on days 1 8 and 15 of cycle 1 and then day 1 of each subsequent cycle Treatment repeats every 28 days for 8 cycles in patients who achieve a complete response CR or up to 17 cycles for patients with a partial response PR or stable disease SD in the absence of disease progression or unacceptable toxicity Patients also receive polatuzumab vedotin IV over 30-90 minutes on day 1 for 6 cycles and lenalidomide orally PO on days 1-21 for 8 cycles in patients who achieve CR or up to 17 cycles Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo positron emission tomography PET computed tomography CT and blood sample collection throughout the study
After completion of study treatment patients are followed up for 2 years
I To determine the safety and tolerability of mosunetuzumab polatuzumab vedotin lenalidomide in relapsedrefractory RR diffuse large B cell lymphoma DLBCL
SECONDARY OBJECTIVE
I To observe and record anti-tumor activity of the combination of mosunetuzumab polatuzumab vedotin and lenalidomide in RR DLBCL
EXPLORATORY OBJECTIVES
I To assess the efficacy in patients that have failed prior polatuzumab vedotin containing regimens ie patients who progressedrelapsed after prior polatuzumab
II To assess anti-tumor activity in patients that a have complete response CR or Deauville score of 3 or worse at day 90 D90 or before after standard of care chimeric antigen receptor CAR T-cell therapy b other patients who have failed prior treatment eg relapse after day 90 from CAR-T or relapsed after other therapies and were not considered candidates for CAR-T
III To identify biomarkers that can predict the response to mosunetuzumab polatuzumab vedotin lenalidomide
IV To describe anti-tumor activity in patients whose tumors have previously failed to respond to polatuzumab ie patients who progressedrelapsed after prior polatuzumab
OUTLINE This is a dose-escalation study of mosunetuzumab followed by a dose-expansion study
Patients receive mosunetuzumab intravenously IV over 2-4 hours on days 1 8 and 15 of cycle 1 and then day 1 of each subsequent cycle Treatment repeats every 28 days for 8 cycles in patients who achieve a complete response CR or up to 17 cycles for patients with a partial response PR or stable disease SD in the absence of disease progression or unacceptable toxicity Patients also receive polatuzumab vedotin IV over 30-90 minutes on day 1 for 6 cycles and lenalidomide orally PO on days 1-21 for 8 cycles in patients who achieve CR or up to 17 cycles Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo positron emission tomography PET computed tomography CT and blood sample collection throughout the study
After completion of study treatment patients are followed up for 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-06477 | REGISTRY | None | None |
| PHI-141 | None | None | None |
| 10601 | OTHER | None | None |
| 10601 | OTHER | None | None |
| UM1CA186717 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186717 |